The present invention generally relates to a dual-filled twin bag system, a package and a method for forming a package. More specifically, the present invention relates to a dual-filled twin bag including dialysis solution in each bag wherein the twin bag is used for administering dialysis solution to a patient undergoing peritoneal dialysis.
It is, of course, generally known to store a dialysis solution in a flexible plastic bag for use in continuous ambulatory peritoneal dialysis (CAPD). The dialysis solution is transferred from the bag to a patient during a dialysis procedure. A second empty bag is provided for draining liquid from a peritoneal cavity of an individual undergoing peritoneal dialysis. In conventional twin bag systems, the empty bag and bag containing solution are interconnected by a set of tubing that attaches to a tubing set that ultimately connects to the patient catheter.
A solution bag, the bag containing the dialysis solution, is generally completely filled and ready for use after a sterilization procedure is performed. The sterilization procedure requires that the bag is oriented on a sterilizing tray or other device to sterilize the solution contained in the bag. Due to the volume of solution in the bag, sterilization is a time-consuming process. That is, due to the volume of solution creating a wide profile of the solution in the bag, heat penetration to effect complete sterilization of the solution, the bag and the tubing set is time-consuming.
To transport a solution bag, a drain bag, and a tubing set to a patient, the combination is placed in an overpouch. The overpouch is designed in order to accommodate the three components. However, it is often difficult and cumbersome to place the three components in an overpouch, particularly when the method is performed automatically. Namely, the tubing set often is tangled with the overpouch or the drain bag during placement into the overpouch. Furthermore, due to the profile obtained by filling a single solution bag, the overall profile of a conventional twin bag product within an overpouch tends to be bulky. This overall bulkiness of a conventional twin bag product itself further requires a correspondingly large shipping carton. Additionally, substantial storage space is required in the home or place at which an individual undergoes peritoneal dialysis. The amount of packaging also generates substantial trash to completely dispose of the product, including the packaging of the product, following use.
At the start of a typical cycle of CAPD, solution is drained from the peritoneal cavity into the drain bag through one line of the tubing set. After draining, a frangible in another line of the tubing set from the solution bag is broken to allow fluid communication between solution in the solution bag to be fed to the peritoneal cavity. Often, for physically or visually impaired patients, the frangibles are difficult to break. In addition, particulate matter from the breaking of the frangible may obstruct the fluid path. Moreover, use of a frangible in a tubing set may cause fibrin clots at the ends of the broken frangible parts.
A need, therefore, exists for an improved solution container and associated tubing set, particularly for use during a peritoneal dialysis procedure, which overcomes the deficiencies known in other systems that use a solution bag and a drain bag for administering a solution to a patient and subsequently drain the solution to a container.
The present invention relates to a dual-filled twin bag, a package including the bag and a method for forming a package for administering a solution. More specifically, the present invention relates to a twin-bag package, particularly useful for administering a solution used in a peritoneal dialysis procedure. The package is formed in such a manner to substantially reduce packaging size requirements and to simplify the packaging procedure.
To this end, the present invention provides a system having a solution bag with an interior holding a dialysis solution and a drain bag having an interior holding a dialysis solution. A tubing set including a length of tubing connects the solution bag and the drain bag.
In an embodiment, the dialysis solution in the solution bag is identical to the dialysis solution in the drain bag.
In an embodiment, the tubing set includes a coiled length of tubing.
In an embodiment, the solution bag and the drain bag are constructed of flexible plastic material.
In an embodiment, the tubing set includes a dialysis solution within the tubing set.
In an embodiment, the system has a first length of coiled tubing and a second length of coiled tubing wherein the first length and the second length are attached to form a multiple ring coil.
In an embodiment, a connector is attached to an end of the tubing set.
In an embodiment, a cap encloses an end of the connector attached to the end of the tubing set. The aforementioned cap may be steam permeable.
In an embodiment, the solution bag and the drain bag are partially filled with the dialysis solution.
In an embodiment, the volumes of the dialysis solution in the solution bag and the drain bag are substantially equal.
In an embodiment, the tubing set is filled with a gas.
In another embodiment of the present invention, a packaged system is provided. The packaged system has a first container having exterior walls defining an interior wherein the interior includes a first solution. A second container having exterior walls defines an interior wherein the interior includes a second solution. A tubing set is sandwiched between one of the exterior walls of the first container and one of the exterior walls of the second container wherein the tubing set connects the first container to the second container.
In an embodiment, the exterior walls of the first container and the second container sandwiching the tubing set are arranged such that the exterior walls are substantially flush with respect to each other.
In an embodiment, a third container has an interior constructed and arranged to completely encompass the first container, the second container and the tubing set.
In an embodiment, the tubing set includes a solution therein.
In an embodiment, the tubing set includes a coiled length of tubing.
In an embodiment, the first container and the second container are constructed from flexible materials.
In an embodiment, the first solution of the first container is identical to the second solution of the second container.
In an embodiment, the solution of the first container is a dialysis solution.
In an embodiment, the first and second solutions are added to the first container and the second container during manufacture of the first container and the second container.
In an embodiment, the first container is a solution bag used during a dialysis procedure.
In an embodiment, the second container is a drain bag for use during a dialysis procedure.
In another embodiment of the present invention, a method is provided for forming a package for use during a peritoneal dialysis procedure. The method comprises the steps of: providing a first container defining an interior; providing a second container defining an interior; connecting the first container and the second container; and filling simultaneously and at least partially the interiors of the first container and the second container with a solution.
In an embodiment, a tubing set is provided including a length of tubing to connect the first container and the second container.
In an embodiment, a third container defining an interior is provided. The first container and the second container are placed in the interior of the third container.
In an embodiment, the tubing set is sandwiched between an exterior wall of the first container and an exterior wall of the second container.
In an embodiment, the first container and the second container include substantially equal amounts of the solution.
In an embodiment, a coiled length of tubing is provided to connect the first container and the second container.
In another embodiment, the first container and the second container are constructed from flexible materials.
In an embodiment, the solution in the first container is a different solution from the solution in the second container.
In an embodiment, the tubing set is filled with a gas.
In another embodiment of the present invention, a method is provided for administering a solution to a patient. The method comprises the steps of: providing a first bag having a portion of the solution therein; providing a second bag having another portion of the solution therein; connecting the first bag and the second bag to provide fluid communication therebetween; transferring the portion of the solution in the first bag to the second bag; and feeding the solution in the second bag to the patient.
In an embodiment, flow of solution into the first bag following transfer to the second bag is prevented.
In an embodiment, the transferring and the feeding are performed without using a frangible.
In an embodiment, the volumes of solutions in the first bag and the second bag are substantially equal.
In an embodiment, the solution is a dialysis solution.
In an embodiment, the solution in the first bag is a different solution than a solution in the second bag.
In an embodiment, the tube connecting the first bag to the second bag is filled with a gas.
It is, therefore, an advantage of the present invention to provide a system, a package and a method for packaging that includes dialysis solution in both a solution bag and a drain bag.
Another advantage of the present invention is to provide a system, a package and a method for performing peritoneal dialysis that does not require the use of frangibles.
Yet another advantage of the present invention is to provide a system, a package and a method for peritoneal dialysis that reduces the overall size and profile of the package.
And, another advantage of the present invention is to provide a system, a package and a method that simplifies the sterilization procedure required for a dialysis solution.
A still further advantage of the present invention is to provide a system, a package and a method that eliminates sticking in the bags, particularly the drain bag, in which solution is not normally provided.
Moreover, an advantage of the present invention is to provide a system, a package and a method that increases heat penetration and reduces overall time required for sterilization.
Another advantage of the present invention is to provide a system, a package and a method that eliminates excess air in the overpouch.
Another advantage of the present invention is to provide a system, a package and a method that eliminates excess volume required in the overpouch.
Yet another advantage of the present invention is to provide a system, a package and a method that uses a smaller overpouch.
Still further, an advantage of the present invention is to provide a system, a package and a method that reduces cost of packaging.
And, another advantage of the present invention is to provide a system, a package and a method that requires a smaller shipping carton for shipping the same number of packaged units thereby requiring less storage space at a home or location of the user or patient.
Moreover, an advantage of the present invention is to provide a system, a package and a method wherein each bag experiences less stress during sterilization.
Yet another advantage of the present invention is to provide a system, a package and a method that eliminates the requirement for bag orientation during sterilization.
A still further advantage of the present invention is to provide a system, a package and a method that allows separate storage of different solutions prior to mixing and subsequent administration to a patient.
And, another advantage of the present invention is to provide a system, a package and a method that stores different solutions separately without use of a frangible.
Still further, an advantage of the present invention is to provide a system, a package and a method that stores two components and/or solutions that are not compatible during manufacturing and/or storage.
Moreover, an advantage of the present invention is to provide a system, a package and a method for producing a sterilized bicarbonate/dextrose solution for peritoneal dialysis.
Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments and from the drawings.